Vancouver, British Columbia--(Newsfile Corp. - April 29, 2021) - iCo Therapeutics ("iCo" or the "Company") (TSXV: ICO) (OTC: ICOTF) today reported financial results for the year ended December 31, 2020. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").
William Jarosz, CEO of iCo Therapeutics Inc., noted "We were very pleased by the progress of our Oral Amp B program during the year with our compound being safe and well tolerated in Phase 1b clinical trials and potential as a therapeutic agent for novel Coronavirus. We are also excited for the new strategic directions that are open for us in this new year with Satellos, and the associated concurrent financing, previously announced."
The Company also announced the resignation of Susan Koppy as President of the Company and from the Board of Directors, effective April 30, 2021. "While I've had a long affiliation with iCo, I now feel that the Company is on a solid trajectory. For personal reasons, it's the right time for me to move on and tender my resignation. I wish the Company every success," noted Susan Koppy.
"We have benefitted from the guidance that Susan has provided for Business Development and thank her for all her hard work," said William Jarosz. The Company expects to appoint new officers and new members to the Board in conjunction with the Satellos transaction.
Operational and Financial Highlights
Corporate
On March 21, 2021, the Company entered into an agreement (the "Arrangement Agreement") providing for the business combination of iCo and Satellos Bioscience Inc. ("Satellos") by way of a plan of arrangement (the "Arrangement") in accordance with Section 192 of the Canada Business Corporations Act (the "CBCA"). Pursuant to the Arrangement, Satellos will become a wholly owned subsidiary of iCo, and the parties expect to complete an amalgamation of iCo and Satellos, with the resulting entity named "Satellos Bioscience Inc." (the "Resulting Issuer"), operating in the life sciences industry. Following the Arrangement, and the Concurrent Financing (described below) shareholders of iCo will hold an approximately 27.7% ownership interest, and the shareholders of Satellos will hold approximately 58.8.% of the outstanding common shares of the Resulting Issuer.
The completion of the Arrangement will result in a reverse takeover of iCo as defined in the policies of the TSX Venture Exchange (the "Exchange"). Completion of the Arrangement is subject to, among other things, the approval of the Exchange, court approval, and approval from iCo and Satellos' shareholders. As part of the Arrangement, iCo has closed a private placement (the "Concurrent Financing") of subscription receipts (the "Subscription Receipts") issuing 85,294,117 subscription receipts at a price of $0.085 per Subscription Receipt for aggregate gross proceeds of approximately C$7.25 million, representing an upsize from the C$6 million financing announced on March 22, 2021. Each Subscription Receipt entitles the holder thereof to receive, upon satisfaction of certain escrow release conditions, and without payment of additional consideration, one common share in the Resulting Issuer. The proceeds from the Concurrent Financing have been placed in escrow and, upon satisfaction of the release conditions and completion of the Arrangement, will be used for research, development, and general corporate expenses of the Resulting Issuer.
Also, subsequent to year end, warrant holders exercised 27,335,000 for proceeds of $1,758,795 to the Company.
Oral Amp B Delivery System
On February 25, 2020, iCo announced the completion of the Phase 1b study in which both (100 mg and 400 mg) doses of the oral Amphotericin B were well tolerated with no adverse events reported, including no signs of kidney or other toxicity.
On April 15, 2020, iCo announced pharmacokinetic results from the Phase 1b study. The oral Amphotericin B at the 100 mg dose achieved a median plasma Cmax of 25 ng AmB/mL and AUC (0-inf) 990 hr* ng/mL after day 1 of dosing and a median plasma Cmax of 44 ng AmB/mL and AUC (0-inf) 1998 hr*ng/mL after 10 day of dosing. This approximate doubling of the AUC (0-inf) measure between day 1 and day 10 was observed not only at the 100 mg dose but at the 400 mg dose as well.
On December 31, 2020, iCo and Skymount Medical, Inc. ("Skymount") announced that they entered into a non-binding Memorandum of Understanding to develop iCo-019, iCo's oral Amphotericin B formulation. Skymount is expected to initially commit up to $US 550,000 for pre-clinical work targeting the use of iCo-019 as a therapeutic product for infections relating to COVID-19.
On March 15, 2021, iCo announced that its wholly owned subsidiary, Amphotericin B Technologies, Inc., entered into an agreement with IIT Research Institute to test the in vivo efficacy of iCo's novel oral amphotericin B asset ("iCo-019") against SARS-CoV-2, the causative agent of COVID-19 in the hACE2 mouse model (the "iCo-019 Study"). iCo anticipates that the iCo-019 Study will be completed by the end of Q2 2021.
Financial results for Year End 2020
We incurred a total comprehensive loss of $1,506,303 for the year ended December 31, 2020 compared to a total comprehensive loss of $1,932,202 for the year ended December 31, 2019, representing a decrease of $425,899. The decrease is primarily the result of lower general and administrative expenses offset by lower research and development tax credits recognized during 2020.
Research and development expenses were $895,112 for the year ended December 31, 2020 compared to $917,475 for the year ended December 31, 2019, representing a decrease of $22,363 or 2%. For both years the research and development expenses primarily reflected contract research expenses for a Phase 1b clinical trial conducted on the Oral Amp B program.
For the year ended December 31, 2020 general and administrative expenses were $760,463 compared to $1,288,198 for the year ended December 31, 2019, representing a decrease of $527,735. The decrease reflects lower consulting and professional fees during the period. The Company's participation in the IMMUNE bankruptcy process last year caused an increase in consulting and professional fees in the prior year.
Liquidity and Outstanding Share Capital
As at December 31, 2020, we had cash and cash equivalents of $65,413 compared to $989,937 as at December 31, 2019. Subsequent to year end, warrant holders exercised 27,335,000 for proceeds of $1,758,795 to the Company.
As at April 29, 2021, we had an unlimited number of authorized common shares with 181,082,713 common shares issued and outstanding.
For complete financial results, please see our filings at www.sedar.com.
About iCo Therapeutics Inc.
iCo Therapeutics identifies existing development stage assets for use in underserved ocular and infectious diseases. Such assets may exhibit utility in non-ophthalmic conditions outside the Company's core focus areas and if so the Company will seek to capture further value via partnerships. iCo shares trade on the TSX Venture Exchange under the symbol "ICO" and on the OTC under the symbol "ICOTF".
For more information, visit the Company website at: www.icotherapeutics.com.
iCo Contact Information
William Jarosz
Chief Executive Officer
iCo Therapeutics
(917) 692-8799
Jarosz@icotherapeutics.com
iCo Therapeutics Inc.
1 604 800 9860
No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward-Looking Statements
Certain statements included in this press release may be considered forward-looking statements" within the meaning of applicable securities laws, which may include, but are not limited to, statements with respect to the completion of the Arrangement, the satisfaction of the escrow release conditions, intended use of proceeds from the financing, progress of the Oral Amp B program, and the potential of the Oral Amp B compounded as a therapeutic agent for the novel Coronavirus. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will," and similar references to future periods. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on iCo's current beliefs as well as assumptions made by and information currently available to iCo and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments, including statements relating to reporting further data regarding studies for Oral Amp Delivery System, the timing of receipt of the statistical analysis for clinical data, the timing, receipt and amount of Australian refundable tax credits, any decrease in research and development expenditures and the completion of additional funding and commencement of additional clinical studies. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based only on information currently available to iCo and speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo in its public securities filings and on its website, actual events may differ materially from current expectations. In evaluating forward-looking statements, readers should consider the risk factors set out herein and in the Company's Annual Information Form dated April 29, 2019, a copy of which is available under iCo's profile on SEDAR at www.sedar.com and as otherwise disclosed in the Company's filings under its profile on SEDAR from time to time. All forward-looking statements are made as of the date of this press release, and iCo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
NOT FOR DISSEMINATION IN THE UNITED STATES OR FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/82380.
